510(k) · Cleared
ClearedVax-D Genesis System (Therapeutic Table)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vax-D Medical Technologies USA, L.C. · ITH Equipment, Traction, Powered
Cleared on Dec 28, 2005 as substantially equivalent to K951622 (Vat-Tech, Inc., 1996) after a 12-day review. Its family tree reaches back 2 generations to 1989. 16 later devices descend from it.
- Decided
- Dec 28, 2005
- Review
- 12 days
- Class
- Class II
- Product code
- ITH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K894435 (1989). 16 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK894435 Vax-T Pelvic Traction BeltVat-Tech, Inc. · 1989
- 1 generation backK951622 Vax-D Therapeutic TableVat-Tech, Inc. · 1996
- This deviceK053503 Vax-D Genesis System (Therapeutic Table)Vax-D Medical Technologies USA, L.C. · 2005
- Descendant · cites it directly · 8 of its ownK053223 Triton/Tru-Trac/TX/Triton DTS TractionChattanooga Group · 2006
- Descendant · cites it directly · 3 of its ownK060735 DRX9000 True Spinal Decompression SystemAxiom Worldwide, Inc. · 2006
- Descendant · 2 generations on · 1 of its ownK151640 Eltrac 471Enraf-Nonius, B.V. · 2015
- Descendant · cites it directly · 1 of its ownK071347 Vax-D Genesis G2 SystemVax-D Medical Technologies, LLC · 2007
- Descendant · 2 generations on · 0 of its ownK243775 True Non-Surgical Spinal Decompression System (DRX9000-SL)Excite Medical of Tampa Bay, LLC · 2025
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K053223Triton/Tru-Trac/TX/Triton DTS TractionChattanooga Group · 2006 · cites it directly8descendants
- K060735DRX9000 True Spinal Decompression SystemAxiom Worldwide, Inc. · 2006 · cites it directly3descendants
- K151640Eltrac 471Enraf-Nonius, B.V. · 2015 · 2 generations on1descendant
- K071347Vax-D Genesis G2 SystemVax-D Medical Technologies, LLC · 2007 · cites it directly1descendant
- K243775True Non-Surgical Spinal Decompression System (DRX9000-SL)Excite Medical of Tampa Bay, LLC · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K894435 | Vax-T Pelvic Traction Belt | Vat-Tech, Inc. | 1989 | — |
| −1 | K951622 | Vax-D Therapeutic Table | Vat-Tech, Inc. | 1996 | — |
| 0 (this device) | K053503 | Vax-D Genesis System (Therapeutic Table) | Vax-D Medical Technologies USA, L.C. | 2005 | — |
| +1 | K053223 | Triton/Tru-Trac/TX/Triton DTS Traction | Chattanooga Group | 2006 | — |
| +1 | K060735 | DRX9000 True Spinal Decompression System | Axiom Worldwide, Inc. | 2006 | — |
| +2 | K151640 | Eltrac 471 | Enraf-Nonius, B.V. | 2015 | — |
| +1 | K071347 | Vax-D Genesis G2 System | Vax-D Medical Technologies, LLC | 2007 | — |
| +2 | K243775 | True Non-Surgical Spinal Decompression System (DRX9000-SL) | Excite Medical of Tampa Bay, LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ITH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ITH device
- #1 K243775 True Non-Surgical Spinal Decompression System…score 10.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K951622 | Vax-D Therapeutic TableSummary page 1…PRODUCT CODE: 89 ITH D PANEL CODE: 870R 6. PREDICATE DEVICE: VAX-U Therapeutic Table (K951622) 7. DEVICE DESCRIPTION distraction tensions to the patient's lumbar The… | 1996 |
What descends from it? (16)
See all 164 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 9.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K053223 (Chattanooga Group, 2006) has gone furthest, with 8 descendants of its own.
- 7 other devices also cite its predicate K951622.
How does its category compare?
All ITH devicesITH Equipment, Traction, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ITH
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITH
132in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITH
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ITH
3in 2025
MAUDE reports naming product code ITH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 2 |
| 2008 | 4 | 132 | 0 | 0 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 1 | — | 2 | 5 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 2 | — | 0 | 5 |
| 2015 | 2 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 5 |
| 2025 | 2 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This therapy provides a primary treatment modality for the management of pain and disability for patients suffering with incapacitating low back pain and sciatica. It is designed to apply decompressive forces to compressive and degenerative injuries of the spine. It has been found to provide relief of pain and symptoms associated with herniated discs, bulging or protruding intervertebral discs, degenerative disc disease, posterior facet syndrome and sciatica.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053503 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053503: Vax-D Genesis System (Therapeutic Table).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053503
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026